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NCT06001762
TRADE: Dose Escalation Tolerability of Abemaciclib in HR+ HER2- Early Stage Breast Cancer
Phase 2 trial testing Abemaciclib in Breast Cancer in 90 participants. Participants enrolled and being followed up; not accepting new ones.
22 January 2025
Quick facts
| Lead sponsor | Dana-Farber Cancer Institute |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 90 |
| Start date | 5 October 2023 |
| Primary completion | 22 January 2025 |
| Estimated completion | 1 January 2027 |
| Sites | 12 locations across United States |
Drugs / interventions tested
- Abemaciclib (abemaciclib) — full drug profile →
- Tamoxifen
- Anastrozole (anastrozole) — full drug profile →
- Letrozole — full drug profile →
- Exemestane (exemestane) — full drug profile →
- LHRH Agonist
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
- Early-stage Breast Cancer — all drugs for Early-stage Breast Cancer →
- High Risk Breast Carcinoma — all drugs for High Risk Breast Carcinoma →
Sponsor
Dana-Farber Cancer Institute
Who can join
18 and older, female only, with Breast Cancer or Early-stage Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In this research study, investigators are testing if a dose-increasing strategy for abemaciclib will have less side effects and be better tolerated than the standard dosage of abemaciclib for participants with early-stage high-risk hormone receptor positive breast cancer. The names of the study drugs involved in this study are: * Abemaciclib (CDK4 and CDK6 inhibitor) * Tamoxifen (Selective estrogen receptor modulator) * Anastrozole/Letrozole (Non-steroidal aromatase inhibitors) * Exemestane (steroidal aromatase inhibitor) * LHRH (Gonadotropin-releasing hormone agonist, or Luteinizing hormone-releasing hormone agonist)
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
TBCRC 035: randomized phase II pharmacodynamic study of standard and reduced-dose palbociclib with endocrine therapy in hormone receptor (HR)-positive previously treated metastatic breast cancer
Jacob S, Mayer E, Kacik N, Storniolo A, et al · · 2026
Verify or expand the search:
- PubMed search for NCT06001762
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Abemaciclib
Trials testing the same drug.
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- NCT07428018 — Pragmatic Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+/HER2- Early Breast Cancer Using Onco · Phase 2 · not yet recruiting
- NCT07191717 — Imlunestrant and Abemaciclib for the Treatment of Estrogen Receptor Positive Breast Cancer in Patients With Minimal Resi · Phase 2 · not yet recruiting
- NCT06498648 — Testing the Addition of an Anti-cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (Gemcitabine) for Soft Tis · Phase 1, PHASE2 · recruiting
- NCT07441369 — Abemaciclib Combined With FOLFOX/FOLFIRI Regimen in Patients With Advanced Colorectal Liver Metastases Cancer · Phase 2 · enrolling by invitation
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Currently open trials in the same condition.
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Other Dana-Farber Cancer Institute trials
Trials by the same sponsor.
- NCT07519200 — Sexual Health and Rehabilitation for Women With Metastatic Breast Cancer (SHARE-MC): An Educational Intervention · NA · not yet recruiting
- NCT07499999 — Randomized Double-Blind Phase II Trial of Baby Exemestane Versus Baby Tamoxifen in Post-Menopausal Women at High Risk fo · Phase 2 · not yet recruiting
- NCT05825469 — Development and Testing of Nutritional Algorithms (NACHO) · NA · not yet recruiting
- NCT07516353 — my.naviGATE: A Guide to After-Treatment Effects for Adolescents and Young Adults · NA · not yet recruiting
- NCT07513324 — Risk-adapted Therapy in HPV-positive Oropharyngeal Cancer Using Circulating Tumor (ct) HPV DNA Profiling (ReACT 2.0) · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06001762 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Dana-Farber Cancer Institute
- Last refreshed: 16 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06001762.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing